Mycophenolic sodium - Generic Drug Details

What are the generic sources for mycophenolic sodium and what is the scope of freedom to operate?

Mycophenolic sodium is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amta, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Concord Biotech Ltd, Rk Pharma, Teva Pharms Usa, Twi Pharms, Wanbang Biopharms, and Novartis, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

Eighteen suppliers are listed for this compound.

Summary for mycophenolic sodium

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	13
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	21
DailyMed Link:	mycophenolic sodium at DailyMed

Recent Clinical Trials for mycophenolic sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
AstraZeneca	Phase 3
University Hospital, Tours	Phase 4
Lee's Pharmaceutical Limited	Phase 4

See all mycophenolic sodium clinical trials

Pharmacology for mycophenolic sodium

Drug Class

Antimetabolite Immunosuppressant

Paragraph IV (Patent) Challenges for MYCOPHENOLIC SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYFORTIC	Delayed-release Tablets	mycophenolic sodium	180 mg	050791	1	2009-06-03
MYFORTIC	Delayed-release Tablets	mycophenolic sodium	360 mg	050791	1	2009-02-02

US Patents and Regulatory Information for mycophenolic sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Concord Biotech Ltd	MYCOPHENOLIC SODIUM	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	211173-001	Dec 13, 2019	AB	RX	No	No
Biocon Pharma	MYCOPHENOLIC SODIUM	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	217031-002	Nov 29, 2023	AB	RX	No	No
Alkem Labs Ltd	MYCOPHENOLIC SODIUM	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	208315-002	Sep 23, 2021	AB	RX	No	No
Twi Pharms	MYCOPHENOLIC SODIUM	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	214289-001	Nov 3, 2021	AB	RX	No	No

Expired US Patents for mycophenolic sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	6,172,107
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-001	Feb 27, 2004	6,025,391
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	6,306,900
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	6,025,391

Mycophenolic sodium Market Analysis and Financial Projection Experimental

Mycophenolic Acid and Mycophenolic Sodium: Market Dynamics and Financial Trajectory

Introduction

Mycophenolic acid, and its derivatives such as mycophenolic sodium, are crucial immunosuppressant drugs used primarily to prevent organ rejection in transplant patients and to treat various autoimmune diseases. Here, we delve into the market dynamics and financial trajectory of mycophenolic sodium, a key formulation of mycophenolic acid.

Market Size and Growth

The global mycophenolic acid market, which includes mycophenolic sodium, was valued at USD 100 million in 2023 and is projected to reach USD 147.7 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[4].

Segmentation of the Market

The market is segmented based on application, product type, and geographical regions. The key applications include immunosuppressive therapy, organ transplantation, treatment of autoimmune diseases, and dermatology. The primary products are mycophenolate mofetil and mycophenolate sodium[4].

Geographical Performance

• North America: This region is expected to register the highest revenue CAGR over the forecast period due to the advanced pharmaceutical industry and significant investments in healthcare infrastructure[1].
• Europe: Europe holds the second-largest market share, with room for growth driven by advancements in bionics and biomedical equipment[1].
• Asia Pacific: The market in this region is expected to grow rapidly due to increasing urban prosperity, higher willingness to pay for organ transplants, and a rising incidence of renal diseases[1].

Product Forms and Usage

Mycophenolic acid is available in two main forms: mycophenolate mofetil and mycophenolate sodium. Mycophenolate sodium, marketed as Myfortic, is an enteric formulation that delivers mycophenolic acid (MPA) and is used in conjunction with other drugs to prevent organ rejection in patients with kidney, heart, or liver transplants[2].

Clinical Efficacy and Safety

Studies have shown that mycophenolate sodium (Myfortic) has similar efficacy to mycophenolate mofetil in preventing acute rejection and graft loss in renal transplant patients. The incidence of treatment failure, including biopsy-proven acute rejection, graft loss, death, and lost to follow-up, was comparable between Myfortic and mycophenolate mofetil-treated patients at 6 and 12 months[2][5].

Cost Trends and Patient Payments

The cost of mycophenolic acid products has seen a significant decline over recent years. From 2008 to 2013, average annualized out-of-pocket payments by patients for mycophenolic acid decreased substantially, with reductions of 71%, 77%, and 79% for kidney, liver, and heart transplant recipients, respectively. This trend is attributed to the availability of generic formulations and changes in healthcare policies[3].

Regulatory and Pharmaceutical Advances

The approval of new formulations and indications by regulatory bodies has been a key driver of market growth. Pharmaceutical companies are focusing on developing innovative formulations and enhancing drug delivery methods to improve therapeutic efficacy and patient compliance. This includes advancements in pharmacogenomics and biotechnology, which tailor medical approaches to maximize therapeutic outcomes[4].

Economic and Social Factors

The expansion of healthcare infrastructure, increasing investments in research projects, and favorable healthcare regulations supporting organ donation and transplant programs are significant factors driving the market. Additionally, the growing incidence of autoimmune diseases and the need for efficient immunosuppressive therapies are contributing to the market's steady expansion[1][4].

Key Players and Market Competition

The mycophenolic acid market is competitive, with key players including Roche Holding AG, Novartis AG, Mylan N.V., Lupin Limited, Teva Pharmaceutical Industries Ltd., and others. These companies are involved in the development of new formulations and the enhancement of existing products to maintain market share and drive growth[4].

Future Outlook

The market for mycophenolic acid, including mycophenolic sodium, is poised for continued growth driven by the increasing demand for immunosuppressive therapies, advancements in pharmaceutical technology, and favorable regulatory environments. As the field of immunology and transplant medicine continues to evolve, the demand for mycophenolic acid is expected to rise, contributing to the market's financial trajectory.

Key Takeaways

• The global mycophenolic acid market is expected to grow from USD 100 million in 2023 to USD 147.7 million by 2031.
• Mycophenolic sodium (Myfortic) is a key formulation used to prevent organ rejection in transplant patients.
• The market is driven by the need for immunosuppressive therapies, advancements in pharmaceutical technology, and favorable regulatory environments.
• North America and Europe are significant markets, with the Asia Pacific region showing rapid growth.
• The cost of mycophenolic acid products has decreased significantly due to the availability of generic formulations.

FAQs

What is mycophenolic acid used for?

Mycophenolic acid is used as an immunosuppressant to prevent organ rejection in patients with kidney, heart, or liver transplants and to treat autoimmune diseases such as Crohn's disease and lupus[1].

What are the main forms of mycophenolic acid?

The main forms are mycophenolate mofetil and mycophenolate sodium, with mycophenolate sodium being marketed as Myfortic[2].

How has the cost of mycophenolic acid products changed over time?

The cost has decreased significantly from 2008 to 2013, with out-of-pocket payments by patients reducing by 71%, 77%, and 79% for kidney, liver, and heart transplant recipients, respectively[3].

Which regions are expected to drive the growth of the mycophenolic acid market?

North America, Europe, and the Asia Pacific region are expected to be key drivers of market growth due to their advanced healthcare infrastructure and increasing demand for immunosuppressive therapies[1][4].

What are the key factors driving the market growth for mycophenolic acid?

Key factors include the growing incidence of autoimmune diseases, advancements in pharmaceutical technology, favorable regulatory environments, and increasing investments in healthcare infrastructure[1][4].

Sources

1. Reports and Data: Mycophenolic Acid Market Size, Share, Trends and Forecast by 2030.
2. FDA: Myfortic® (mycophenolic acid) delayed-release tablets.
3. Clinical Journal of the American Society of Nephrology: Secular Trends in the Cost of Immunosuppressants after Solid Organ Transplantation.
4. Market Research Intellect: Mycophenolic Acid Market Size and Projections.
5. FDA: Myfortic (mycophenolic acid).